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Risperdal (Risperidone) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following findings are based on the short-term, placebo-controlled, North American, premarketing trials for schizophrenia and acute bipolar mania, and are followed by a description of adverse events and other safety measures in short-term, placebo-controlled trials in pediatric patients treated for irritability associated with autistic disorder. In patients with Bipolar I Disorder, treatment-emergent adverse events are presented separately for risperidone as monotherapy and as adjunctive therapy to mood stabilizers.

Certain portions of the discussion below relating to objective or numeric safety parameters, namely dose-dependent adverse events, vital sign changes, weight gain, laboratory changes, and ECG changes are derived from studies in patients with schizophrenia. However, this information is also generally applicable to bipolar mania and pediatric patients with autistic disorder.

Associated With Discontinuation of Treatment

Schizophrenia

Approximately 9% (244/2607) of RISPERDAL® (risperidone)-treated patients in Phase 2 and 3 studies discontinued treatment due to an adverse event, compared with about 7% on placebo and 10% on active control drugs. The more common events (≥0.3%) associated with discontinuation and considered to be possibly or probably drug-related included:

Adverse EventRISPERDAL®Placebo
Extrapyramidal symptoms2.1%0%
Dizziness0.7%0%
Hyperkinesia0.6%0%
Somnolence0.5%0%
Nausea0.3%0%

Suicide attempt was associated with discontinuation in 1.2% of RISPERDAL®-treated patients compared to 0.6% of placebo patients, but, given the almost 40-fold greater exposure time in RISPERDAL® compared to placebo patients, it is unlikely that suicide attempt is a RISPERDAL®-related adverse event (see PRECAUTIONS). Discontinuation for extrapyramidal symptoms was 0% in placebo patients, but 3.8% in active-control patients in the Phase 2 and 3 trials.

Bipolar Mania

In the US placebo-controlled trial with risperidone as monotherapy, approximately 8% (10/134) of RISPERDAL®-treated patients discontinued treatment due to an adverse event, compared with approximately 6% (7/125) of placebo-treated patients. The adverse events associated with discontinuation and considered to be possibly, probably, or very likely drug-related included paroniria, somnolence, dizziness, extrapyramidal disorder, and muscle contractions involuntary. Each of these events occurred in one RISPERDAL®-treated patient (0.7%) and in no placebo-treated patients (0%).

In the US placebo-controlled trial with risperidone as adjunctive therapy to mood stabilizers, there was no overall difference in the incidence of discontinuation due to adverse events (4% for RISPERDAL® vs. 4% for placebo).

Incidence in Controlled Trials

Commonly Observed Adverse Events in Controlled Clinical Trials

Schizophrenia

In two 6- to 8-week placebo-controlled trials, spontaneously-reported, treatment-emergent adverse events with an incidence of 5% or greater in at least one of the RISPERDAL® groups and at least twice that of placebo were anxiety, somnolence, extrapyramidal symptoms, dizziness, constipation, nausea, dyspepsia, rhinitis, rash, and tachycardia.

Adverse events were also elicited in one of these two trials (i.e., in the fixed-dose trial comparing RISPERDAL® at doses of 2, 6, 10, and 16 mg/day with placebo) utilizing a checklist for detecting adverse events, a method that is more sensitive than spontaneous reporting. By this method, the following additional common and drug-related adverse events occurred at an incidence of at least 5% and twice the rate of placebo: increased dream activity, increased duration of sleep, accommodation disturbances, reduced salivation, micturition disturbances, diarrhea, weight gain, menorrhagia, diminished sexual desire, erectile dysfunction, ejaculatory dysfunction, and orgastic dysfunction.

Bipolar Mania

In the US placebo-controlled trial with risperidone as monotherapy, the most commonly observed adverse events associated with the use of RISPERDAL® (incidence of 5% or greater and at least twice that of placebo) were somnolence, dystonia, akathisia, dyspepsia, nausea, parkinsonism, vision abnormal, and saliva increased. In the US placebo-controlled trial with risperidone as adjunctive therapy to mood stabilizers, the most commonly observed adverse events associated with the use of RISPERDAL® were somnolence, dizziness, parkinsonism, saliva increased, akathisia, abdominal pain, and urinary incontinence.

Adverse Events Occurring at an Incidence of 1% or More Among RISPERDAL®-Treated Patients - Schizophrenia

The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent among RISPERDAL®-treated patients treated at doses of ≤10 mg/day than among placebo-treated patients in the pooled results of two 6- to 8-week controlled trials. Patients received RISPERDAL® doses of 2, 6, 10, or 16 mg/day in the dose comparison trial, or up to a maximum dose of 10 mg/day in the titration study. This table shows the percentage of patients in each dose group (≤10 mg/day or 16 mg/day) who spontaneously reported at least one episode of an event at some time during their treatment. Patients given doses of 2, 6, or 10 mg did not differ materially in these rates. Reported adverse events were classified using the World Health Organization preferred terms.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in this clinical trial. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

Table 1. Incidence of Treatment-Emergent Adverse Events in 6- to 8-Week Controlled Clinical Trials in SchizophreniaEvents reported by at least 1% of patients treated with RISPERDAL®≤10 mg/day are included, and are rounded to the nearest %. Comparative rates for RISPERDAL® 16 mg/day and placebo are provided as well. Events for which the RISPERDAL® incidence (in both dose groups) was equal to or less than placebo are not listed in the table, but included the following: nervousness, injury, and fungal infection.
 RISPERDAL® 
Body System/
Preferred Term
≤10mg/day
(N=324)
16 mg/day
(N=77)
Placebo
(N=142)
Psychiatric
  Insomnia26%23%19%
  Agitation22%26%20%
  Anxiety12%20%9%
  Somnolence3%8%1%
  Aggressive reaction1%3%1%
Central & peripheral nervous system
  Extrapyramidal symptomsIncludes tremor, dystonia, hypokinesia, hypertonia, hyperkinesia, oculogyric crisis, ataxia, abnormal gait, involuntary muscle contractions, hyporeflexia, akathisia, and extrapyramidal disorders. Although the incidence of 'extrapyramidal symptoms' does not appear to differ for the '10 mg/day' group and placebo, the data for individual dose groups in fixed dose trials do suggest a dose/response relationship (see ADVERSE REACTIONS– Dose Dependency of Adverse Events).17%34%16%
  Headache14%12%12%
  Dizziness4%7%1%
Gastrointestinal
  Constipation7%13%3%
  Nausea6%4%3%
  Dyspepsia5%10%4%
  Vomiting5%7%4%
  Abdominal pain4%1%0%
  Saliva increased2%0%1%
  Toothache2%0%0%
Respiratory system
  Rhinitis10%8%4%
  Coughing3%3%1%
  Sinusitis2%1%1%
  Pharyngitis2%3%0%
  Dyspnea1%0%0%
Body as a whole – general
  Back pain2%0%1%
  Chest pain2%3%1%
  Fever2%3%0%
Dermatological
  Rash2%5%1%
  Dry skin2%4%0%
  Seborrhea1%0%0%
Infections
  Upper respiratory3%3%1%
Visual
  Abnormal vision2%1%1%
Musculo-Skeletal
  Arthralgia2%3%0%
Cardiovascular
  Tachycardia3%5%0%

Adverse Events Occurring at an Incidence of 2% or More Among RISPERDAL®-Treated Patients - Bipolar Mania

Tables 2 and 3 display adverse events that occurred at an incidence of 2% or more, and were more frequent among patients treated with flexible doses of RISPERDAL® (1–6 mg daily as monotherapy and as adjunctive therapy to mood stabilizers, respectively) than among patients treated with placebo. Reported adverse events were classified using the World Health Organization preferred terms.

Table 2. Incidence of Treatment-Emergent Adverse Events in a 3-Week, Placebo-Controlled Trial - Monotherapy in Bipolar ManiaEvents reported by at least 2% of patients treated with RISPERDAL® are included and are rounded to the nearest %. Events reported by at least 2% of patients treated with RISPERDAL® that were less than the incidence reported by patients treated with placebo are not listed in the table, but included the following: headache, tremor, insomnia, constipation, back pain, upper respiratory tract infection, pharyngitis, and arthralgia.
Body System/
Preferred Term
RISPERDAL®
(N=134)
Placebo
(N=125)
Central & peripheral nervous system
  Dystonia18%6%
  Akathisia16%6%
  Dizziness11%9%
  Parkinsonism6%3%
  Hypoaesthesia2%1%
Psychiatric
  Somnolence28%7%
  Agitation8%6%
  Manic reaction8%6%
  Anxiety4%2%
  Concentration impaired2%1%
Gastrointestinal system
  Dyspepsia11%6%
  Nausea11%2%
  Saliva increased5%1%
  Mouth dry3%2%
Body as a whole – general
  Pain5%3%
  Fatigue4%2%
  Injury2%0%
Respiratory system
  Sinusitis4%1%
  Rhinitis3%2%
  Coughing2%2%
Skin and appendages
  Acne2%0%
  Pruritus2%1%
Musculo-Skeletal
  Myalgia5%2%
  Skeletal pain2%1%
Metabolic and nutritional
  Weight increase2%0%
Vision disorders
  Vision abnormal6%2%
Cardiovascular, general
  Hypertension3%1%
  Hypotension2%0%
Heart rate and rhythm
  Tachycardia3%2%
Table 3. Incidence of Treatment-Emergent Adverse Events in a 3-Week, Placebo-Controlled Trial - Adjunctive Therapy in Bipolar ManiaEvents reported by at least 2% of patients treated with RISPERDAL® are included and are rounded to the nearest %. Events reported by at least 2% of patients treated with RISPERDAL® that were less than the incidence reported by patients treated with placebo are not listed in the table, but included the following: dyspepsia, nausea, vomiting, headache, tremor, insomnia, chest pain, fatigue, pain, skeletal pain, hypertension, and vision abnormal.
 RISPERDAL®
+ Mood Stabilizer
Placebo
+ Mood Stabilizer
Body System/
Preferred Term
(N=52)(N=51)
Gastrointestinal system
  Saliva increased10%0%
  Diarrhea8%4%
  Abdominal pain6%0%
  Constipation6%4%
  Mouth dry6%4%
  Tooth ache4%0%
  Tooth disorder4%0%
Central & peripheral nervous system
  Dizziness14%2%
  Parkinsonism14%4%
  Akathisia8%0%
  Dystonia6%4%
Psychiatric
  Somnolence25%12%
  Anxiety6%4%
  Confusion4%0%
Respiratory system
  Rhinitis8%4%
  Pharyngitis6%4%
  Coughing4%0%
Body as a whole - general
  Asthenia4%2%
Urinary system
  Urinary incontinence6%2%
Heart rate and rhythm
  Tachycardia4%2%
Metabolic and nutritional
  Weight increase4%2%
Skin and appendages
  Rash4%2%

Dose Dependency of Adverse Events

Extrapyramidal Symptoms

Data from two fixed-dose trials provided evidence of dose-relatedness for extrapyramidal symptoms associated with risperidone treatment.

Two methods were used to measure extrapyramidal symptoms (EPS) in an 8-week trial comparing 4 fixed doses of risperidone (2, 6, 10, and 16 mg/day), including (1) a parkinsonism score (mean change from baseline) from the Extrapyramidal Symptom Rating Scale, and (2) incidence of spontaneous complaints of EPS:

Dose GroupsPlaceboRis 2Ris 6Ris 10Ris 16
Parkinsonism1.20.91.82.42.6
EPS Incidence13%13%16%20%31%

Similar methods were used to measure extrapyramidal symptoms (EPS) in an 8-week trial comparing 5 fixed doses of risperidone (1, 4, 8, 12, and 16 mg/day):

Dose GroupsRis 1Ris 4Ris 8Ris 12Ris 16
Parkinsonism0.61.72.42.94.1
EPS Incidence7%12%18%18%21%

Other Adverse Events

Adverse event data elicited by a checklist for side effects from a large study comparing 5 fixed doses of RISPERDAL® (1, 4, 8, 12, and 16 mg/day) were explored for dose-relatedness of adverse events. A Cochran-Armitage Test for trend in these data revealed a positive trend (p<0.05) for the following adverse events: sleepiness, increased duration of sleep, accommodation disturbances, orthostatic dizziness, palpitations, weight gain, erectile dysfunction, ejaculatory dysfunction, orgastic dysfunction, asthenia/lassitude/increased fatigability, and increased pigmentation.

Vital Sign Changes

RISPERDAL® is associated with orthostatic hypotension and tachycardia (see PRECAUTIONS).

Weight Changes

The proportions of RISPERDAL® and placebo-treated patients meeting a weight gain criterion of ≥ 7% of body weight were compared in a pool of 6- to 8-week, placebo-controlled trials, revealing a statistically significantly greater incidence of weight gain for RISPERDAL® (18%) compared to placebo (9%).

Laboratory Changes

A between-group comparison for 6- to 8-week placebo-controlled trials revealed no statistically significant RISPERDAL®/placebo differences in the proportions of patients experiencing potentially important changes in routine serum chemistry, hematology, or urinalysis parameters. Similarly, there were no RISPERDAL®/placebo differences in the incidence of discontinuations for changes in serum chemistry, hematology, or urinalysis. However, RISPERDAL® administration was associated with increases in serum prolactin (see PRECAUTIONS).

ECG Changes

Between-group comparisons for pooled placebo-controlled trials revealed no statistically significant differences between risperidone and placebo in mean changes from baseline in ECG parameters, including QT, QTc, and PR intervals, and heart rate. When all RISPERDAL® doses were pooled from randomized controlled trials in several indications, there was a mean increase in heart rate of 1 beat per minute compared to no change for placebo patients. In short-term schizophrenia trials, higher doses of risperidone (8–16 mg/day) were associated with a higher mean increase in heart rate compared to placebo (4–6 beats per minute).

Adverse Events and Other Safety Measures in Pediatric Patients With Autistic Disorder

In the two 8-week, placebo-controlled trials in pediatric patients treated for irritability associated with autistic disorder (n=156), two patients (one treated with RISPERDAL® and one treated with placebo) discontinued treatment due to an adverse event.

In addition to spontaneous reporting, in one of the studies, adverse events were also elicited from a checklist for detecting selected events, a method that is more sensitive than spontaneous reporting.

The most common adverse events with RISPERDAL® that occurred at an incidence equal to or greater than 5% and at a rate of at least twice that of placebo are shown in Table 4.

Table 4 Incidence of Treatment-Emergent Adverse Events in Two 8-Week, Placebo-Controlled Trials in Pediatric Patients with Autistic Disorder
Body System Preferred TermRISPERDAL® (n=76)Placebo (n=80)
Psychiatric
Somnolence67%23%
Appetite increased49%19%
Confusion5%0%
Gastrointestinal
Saliva increased22%6%
Constipation21%8%
Dry mouth13%6%
Body as a whole-general
Fatigue42%13%
Central & peripheral nervous system
Tremor12%1%
Dystonia12%6%
Dizziness9%3%
Automatism7%1%
Dyskinesia7%0%
Parkinsonism8%0%
Respiratory
Upper respiratory tract infection34%15%
Metabolic and nutritional
Weight increase5%0%
Heart rate and rhythm
Tachycardia7%0%

Weight increase was reported more frequently with RISPERDAL® than with placebo. The average weight increase over 8 weeks was 2.6 kg in patients treated with RISPERDAL® compared with 0.9 kg in patients treated with placebo. (See also PRECAUTIONS– Pediatric Use – Weight Gain.)

There was a higher incidence of adverse events reflecting extrapyramidal symptoms (EPS) in the RISPERDAL® group (27.6%) compared with the placebo group (10.0%). In addition, between-group comparison of the severity of EPS were assessed objectively by the following rating instruments: the Simpson-Angus Rating Scale (SARS) and the Abnormal Involuntary Movement Scale (AIMS) in one study, and the Extrapyramidal Symptom Rating Scale (ESRS) in the other study. The mean changes between baseline and endpoint in the total ESRS score were –0.3 in the RISPERDAL® group and –0.4 in the placebo group. The median change from baseline to endpoint was 0 in both treatment groups for each EPS rating scale.

Somnolence was the most frequent adverse event, and was reported at a higher incidence in the RISPERDAL® group compared with the placebo group. The vast majority of cases (96%) were either mild or moderate in severity. These events were most often of early onset with peak incidence occurring during the first 2 weeks of treatment, and median duration was 16 days. Patients experiencing persistent somnolence may benefit from a change in dosing regimen (see DOSAGE AND ADMINISTRATION– Irritability Associated with Autistic Disorder – Pediatrics [Children and Adolescents ]).

Other Events Observed During the Premarketing Evaluation of RISPERDAL®

During its premarketing assessment, multiple doses of RISPERDAL® were administered to 2607 adult patients with schizophrenia and 1923 pediatric patients in Phase 2 and 3 studies. The conditions and duration of exposure to RISPERDAL® varied greatly, and included (in overlapping categories) open-label and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and short-term or longer-term exposure. In most studies, untoward events associated with this exposure were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories. In two large studies, adverse events were also elicited utilizing the UKU (direct questioning) side effect rating scale, and these events were not further categorized using standard terminology. (Note: These events are marked with an asterisk in the listings that follow.)

In the listings that follow, spontaneously reported adverse events were classified using World Health Organization (WHO) preferred terms. The frequencies presented, therefore, represent the proportion of the 2607 adult or 1923 pediatric patients exposed to multiple doses of RISPERDAL® who experienced an event of the type cited on at least one occasion while receiving RISPERDAL®. All reported events are included, except those already listed in Table 1, those events for which a drug cause was remote, and those event terms which were so general as to be uninformative. It is important to emphasize that, although the events reported occurred during treatment with RISPERDAL®, they were not necessarily caused by it. Serious adverse reactions experienced by the pediatric population were similar to those seen in the adult population (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Psychiatric Disorders

Frequent: increased dream activity [Incidence based on elicited reports.] , diminished sexual desire, nervousness. Infrequent: impaired concentration, depression, apathy, catatonic reaction, euphoria, increased libido, amnesia. Rare: emotional lability, nightmares, delirium, withdrawal syndrome, yawning.

Central and Peripheral Nervous System Disorders

Frequent: increased sleep duration. Infrequent: dysarthria, vertigo, stupor, paraesthesia, confusion. Rare: aphasia, cholinergic syndrome, hypoesthesia, tongue paralysis, leg cramps, torticollis, hypotonia, coma, migraine, hyperreflexia, choreoathetosis.

Gastrointestinal Disorders

Frequent: anorexia, reduced salivation. Infrequent: flatulence, diarrhea, increased appetite, stomatitis, melena, dysphagia, hemorrhoids, gastritis. Rare: fecal incontinence, eructation, gastroesophageal reflux, gastroenteritis, esophagitis, tongue discoloration, cholelithiasis, tongue edema, diverticulitis, gingivitis, discolored feces, GI hemorrhage, hematemesis.

Body as a Whole/General Disorders

Frequent: fatigue. Infrequent: edema, rigors, malaise, influenza-like symptoms. Rare: pallor, enlarged abdomen, allergic reaction, ascites, sarcoidosis, flushing.

Respiratory System Disorders

Infrequent: hyperventilation, bronchospasm, pneumonia, stridor. Rare : asthma, increased sputum, aspiration.

Skin and Appendage Disorders

Frequent: increased pigmentation, photosensitivity Infrequent: increased sweating, acne, decreased sweating, alopecia, hyperkeratosis, pruritus, skin exfoliation. Rare: bullous eruption, skin ulceration, aggravated psoriasis, furunculosis, verruca, dermatitis lichenoid, hypertrichosis, genital pruritus, urticaria.

Cardiovascular Disorders

Infrequent: palpitation, hypertension, hypotension, AV block, myocardial infarction. Rare: ventricular tachycardia, angina pectoris, premature atrial contractions, T wave inversions, ventricular extrasystoles, ST depression, myocarditis.

Vision Disorders

Infrequent: abnormal accommodation, xerophthalmia. Rare: diplopia, eye pain, blepharitis, photopsia, photophobia, abnormal lacrimation.

Metabolic and Nutritional Disorders

Infrequent: hyponatremia, weight increase, creatine phosphokinase increase, thirst, weight decrease, diabetes mellitus. Rare: decreased serum iron, cachexia, dehydration, hypokalemia, hypoproteinemia, hyperphosphatemia, hypertriglyceridemia, hyperuricemia, hypoglycemia.

Urinary System Disorders

Frequent: polyuria/polydipsia. Infrequent: urinary incontinence, hematuria, dysuria. Rare: urinary retention, cystitis, renal insufficiency.

Musculo-Skeletal System Disorders

Infrequent: myalgia. Rare: arthrosis, synostosis, bursitis, arthritis, skeletal pain.

Reproductive Disorders, Female

Frequent: menorrhagia, orgastic dysfunction, dry vagina Infrequent: nonpuerperal lactation, amenorrhea, female breast pain, leukorrhea, mastitis, dysmenorrhea, female perineal pain, intermenstrual bleeding, vaginal hemorrhage.

Liver and Biliary System Disorders

Infrequent: increased SGOT, increased SGPT. Rare: hepatic failure, cholestatic hepatitis, cholecystitis, cholelithiasis, hepatitis, hepatocellular damage.

Platelet, Bleeding, and Clotting Disorders

Infrequent: epistaxis, purpura. Rare: hemorrhage, superficial phlebitis, thrombophlebitis, thrombocytopenia.

Hearing and Vestibular Disorders

Rare: tinnitus, hyperacusis, decreased hearing.

Red Blood Cell Disorders

Infrequent: anemia, hypochromic anemia. Rare: normocytic anemia.

Reproductive Disorders, Male

Frequent: erectile dysfunction Infrequent: ejaculation failure.

White Cell and Resistance Disorders

Infrequent: granulocytopenia Rare: leukocytosis, lymphadenopathy, leucopenia, Pelger-Huet anomaly.

Endocrine Disorders

Rare: gynecomastia, male breast pain, antidiuretic hormone disorder.

Special Senses

Rare: bitter taste.

Postintroduction Reports

Adverse events reported since market introduction which were temporally (but not necessarily causally) related to RISPERDAL® therapy, include the following: anaphylactic reaction, angioedema, apnea, atrial fibrillation, cerebrovascular disorder, including cerebrovascular accident, diabetes mellitus aggravated, including diabetic ketoacidosis, hyperglycemia, intestinal obstruction, jaundice, mania, pancreatitis, Parkinson's disease aggravated, pituitary adenomas, pulmonary embolism, precocious puberty, and QT prolongation. There have been rare reports of sudden death and/or cardiopulmonary arrest in patients receiving RISPERDAL®. A causal relationship with RISPERDAL® has not been established. It is important to note that sudden and unexpected death may occur in psychotic patients whether they remain untreated or whether they are treated with other antipsychotic drugs.



REPORTS OF SUSPECTED RISPERDAL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Risperdal. The information is not vetted and should not be considered as verified clinical evidence.

Possible Risperdal side effects / adverse reactions in female

Reported by a physician from Spain on 2011-10-03

Patient: female

Reactions: Drug Tolerance Decreased, Dystonia

Adverse event resulted in: hospitalization

Suspect drug(s):
Risperdal



Possible Risperdal side effects / adverse reactions in 75 year old male

Reported by a physician from United Kingdom on 2011-10-03

Patient: 75 year old male

Reactions: Aortic Aneurysm

Suspect drug(s):
Risperdal
    Administration route: Oral
    Indication: Dementia Alzheimer's Type

Risperdal
    Administration route: Oral



Possible Risperdal side effects / adverse reactions in 74 year old female

Reported by a pharmacist from France on 2011-10-04

Patient: 74 year old female

Reactions: Thrombocytopenia

Suspect drug(s):
Depakene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-04-21
    End date: 2009-07-08

Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-04-23

Risperdal
    Administration route: Oral

Risperdal
    Administration route: Oral
    End date: 2009-06-26

Akineton
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-04-21
    End date: 2009-06-26

Urbanyl
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-04-29
    End date: 2009-06-23

Zolpidem
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-04-21
    End date: 2009-07-13

Tiapride Panpharma
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-06-08
    End date: 2009-06-23



See index of all Risperdal side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-30

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